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Cardiac Contractility Modulation Therapy in Amyloid Cardiomyopathy Patients With Heart Failure

NCT05167799 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2021-12-22

No results posted yet for this study

Summary

The primary aim of this observational registry is to evaluate the efficacy of CCM in patients with heart failure with mid-range or reduced EF and diagnosis of TTR amyloidosis. The efficacy will be evaluated in terms of composite of occurrence of heart failure-related hospitalizations and/or acute intravenous interventions (IVI) at 12-month follow up compared to those reported 12 months before CCM implantation. Among the secondary endpoints, clinical functional status, quality of life, drug changes and Echocardiographic parameters will be evaluated and compared from baseline to follow up.

Conditions

Interventions

DEVICE

Cardiac Contractility Modulation (CCM)

Patients will be implanted with CCM device according to indications, to improve Heart Failure symptoms and then enrolled in the Registry if they fullfil Inclusion and Exclusion Criteria (First of all if they are diagnosed with TTR Amyloidosis)

Sponsors & Collaborators

  • Ospedale C & G Mazzoni

    lead OTHER

Principal Investigators

  • Procolo Marchese, MD · Ospedale Mazzoni (Ascoli Piceno)

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-13
Primary Completion
2023-12-01
Completion
2024-06-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05167799 on ClinicalTrials.gov